Principal Epidemiologist, FSP

JOB DESCRIPTION

The Principal Epidemiologist will Leads high-complexity epidemiology, pharmacoepidemiology and RWE workstreams from question framing through protocol/SAP development, collaborating with analysts/programmers/vendors, and delivery of scientifically defensible, client-ready outputs. Serves as a scientific escalation point, maintains clear status/risk visibility, and mentors staff while applying good practice and regulatory expectations for observational evidence.

RESPONSIBILITIES

Responsibilities:

Lead development of key scientific deliverables, including study concepts, protocols, and SAPs, ensuring scientific rigor and operational feasibility. Respond to rapid epidemiological requests, including safety questions and information requests; frame uncertainty and limitations clearly for decision-makers. Evaluate and recommend fit-for-purpose real-world datasets (e.g., EHR and medical claims), including relevance, completeness, traceability, and key bias risks. When applicable, assess or support use of registries for evidence generation and advise on strengths/limitations for the research question. Apply good pharmacoepidemiology practice across planning, conduct, interpretation, and communication of results (including sensitivity analyses and bias minimization). Lead/oversee literature review deliverables (rapid or systematic as needed), including development/review of literature search strategies suitable for client release. Use recognized reporting/transparency standards for observational studies and routinely collected health data. Provide scientific oversight of execution with internal analysts/programmers and/or external vendors; ensure quality review and contribute to inspection/audit readiness. Communicate proactively with client and internal stakeholders (e.g., Safety/Regulatory/Clinicians), maintaining clear status updates, risks, and mitigation plans. Mentor and coach colleagues on study design, bias minimization, and scientific writing; act as a point of escalation for complex methodological issues. Contribute to capability building through reusable templates, best practices, and continuous improvement, consistent with Cytel-style senior scientific roles (attachments assumed as templates).

QUALIFICATIONS

Qualifications /

Skills:

Education:

PhD in Epidemiology (or related field) preferred; Master's is acceptable with significant, directly relevant experience.

Experience:

At least 8 years in pharmacoepidemiology/RWE/observational epidemiology within pharma/biotech/CRO/consultancy/regulator or equivalent applied setting; demonstrated leadership of complex studies. Pharmacoepidemiology training preferred, with demonstrated application of good practice principles in planning, conduct, and interpretation. Proven authorship and/or final-signoff responsibility for protocols and SAPs (or equivalent analysis plans) for observational/RWE studies. Demonstrated experience with multiple real-world data types (at least two of: claims, EHR, registries, linked datasets), including endpoint definition and feasibility assessment. Strong working knowledge of pharmacovigilance-oriented evidence needs and safety assessment framing for observational data. Advanced scientific writing (protocols, SAPs, reports, manuscripts) and ability to communicate methods and results to senior scientific and non-technical stakeholders. Literature review expertise including (e.g, PubMed) proficiency; ability to construct reproducible searches and document search methods when needed. Strong stakeholder management, proactive risk communication, and ability to navigate challenging discussions constructively. Mentorship capability and track record of elevating team quality/efficiency through coaching and knowledge sharing.